FDAMay 8, 2019device
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
What to do
FDA enforcement status: Terminated
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-88002019-12-20
- FDABi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-88002019-12-20
- FDABi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-88002019-12-20
- FDABUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-88002019-12-20
- FDABUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-88002019-12-20
- FDABUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-88002019-12-20
- FDABUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-88002019-12-20
- FDABAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-88002019-12-20
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